Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000… — Class II medical device recall Z-1565-2026
Ongoing recall by Abbott Diagnostics Scarborough, Inc., reported 2026-03-25, distributed nationwide. It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product I
| Recall number | Z-1565-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diagnostics Scarborough, Inc., Scarborough, ME, United States |
| Recall initiated | 2026-02-09 |
| Classified | 2026-03-13 |
| Reported by FDA | 2026-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 111,984 units |
| UPC / GTIN / UDI-DI | 10811877010422 |
| Lot numbers | 000X133126, 2027 |
| Model numbers | 427-000 |
Product
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable
Reason for recall
It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1565-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.